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FDA 510(k)

METAL OPAQUER

K-Number: K110859 · 2011-06-23

ApplicantApex Dental Materials, Inc.
Decision Date2011-06-23
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

METAL OPAQUER is the device name listed in this FDA 510(k) record. The listed applicant is Apex Dental Materials, Inc.. It received FDA 510(k) clearance on 2011-06-23 under 510(k) number K110859. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METAL OPAQUER?

METAL OPAQUER is a medical device that received FDA 510(k) clearance on 2011-06-23. The listed applicant is Apex Dental Materials, Inc.. The 510(k) number is K110859.

When did METAL OPAQUER receive FDA 510(k) clearance?

METAL OPAQUER received FDA 510(k) clearance on 2011-06-23, under 510(k) number K110859.

Who is the listed applicant for METAL OPAQUER?

The FDA 510(k) record lists Apex Dental Materials, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METAL OPAQUER?

The FDA product code for METAL OPAQUER is EBF.

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Other records listing Apex Dental Materials, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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